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Could a muscle relaxant lift depression? new trial underway

NCT ID NCT07621237

Symptom relief Sponsor: Tonix Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether TNX-102 SL, a tablet taken under the tongue at bedtime, can improve depression symptoms in adults with moderate to severe major depressive disorder. About 360 participants will receive either the drug or a placebo nightly for 6 weeks. Researchers will measure changes in depression scores and monitor safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TNX-102 SL (cyclobenzaprine) taken as a tablet under the tongue at bedtime
What this could lead to
If it works, this could offer a new nightly treatment option for people with major depression, potentially easing symptoms with a different approach than standard antidepressants.
What could go wrong
This is an early Phase 2 trial, so results may not confirm effectiveness. The drug is a muscle relaxant repurposed for depression, and it may cause side effects like drowsiness or dizziness. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary DSM-5 diagnosis of current MDD. * The duration of the current MDE must be between 6 weeks and 18 months. * Without psychotic or catatonic features. * Capable of reading and understanding English and able to provide written informed consent to participate. Exclusion Criteria: * Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa, * Diagnosis of borderline personality disorder that is known, suspected * Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD. * Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence. * History of substance use disorder and/or alcohol use disorder during the preceding 12 months * Use of antidepressants (including ketamine/esketamine, St. John's Wort, S-adenosyl methionine, and/or trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Major depressive disorder (MDD) Major depressive episode (MDE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Activmed Practices & Research, Llc - Methuen

    NOT_YET_RECRUITING

    Methuen, Massachusetts, 01844, United States

  • Artemis Institute For Clinical Research - San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Austin Clinical Trial Partners

    NOT_YET_RECRUITING

    Austin, Texas, 78737, United States

  • Boeson Research Pvu

    NOT_YET_RECRUITING

    Provo, Utah, 84604, United States

  • Central Miami Medical Institute Llc.

    NOT_YET_RECRUITING

    Miami, Florida, 33125, United States

  • Chicago Research Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60634, United States

  • Clinical Neuroscience Solutions Inc. - Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions Inc. - Memphis

    NOT_YET_RECRUITING

    Mephis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions Inc. - Orlando

    RECRUITING

    Orlando, Florida, 32801, United States

  • Coastal Carolina Research Center

    NOT_YET_RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Delricht Research - New Orleans

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Delricht Research - Plano

    NOT_YET_RECRUITING

    Plano, Texas, 75024, United States

  • Delricht Research - Rockville

    NOT_YET_RECRUITING

    Rockville, Maryland, 20852, United States

  • Evergreen Clinical Trials

    NOT_YET_RECRUITING

    Norcross, Georgia, 30092, United States

  • IMA Clinical Research- Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85012, United States

  • Ima Clinical Research - Nyc Midtown

    NOT_YET_RECRUITING

    New York, New York, 10036, United States

  • Inland Psychiatric Medical Group, Inc. - Chino

    NOT_YET_RECRUITING

    Chino, California, 91710, United States

  • K2 Medical Research - Maitland

    NOT_YET_RECRUITING

    Maitland, Florida, 32751, United States

  • K2 Medical Research - Tampa

    NOT_YET_RECRUITING

    Tampa, Florida, 33634, United States

  • Medical Research Group of Central Florida

    NOT_YET_RECRUITING

    Orange City, Florida, 32763, United States

  • Nrc Research Institute

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Redbird Research

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Revival Research Institute, Llc - McKinney, Tx

    NOT_YET_RECRUITING

    McKinney, Texas, 75071, United States

  • Sunwise Clinical Research, Llc

    NOT_YET_RECRUITING

    Walnut Creek, California, 94596, United States

  • Synergy Research - San Diego

    NOT_YET_RECRUITING

    Lemon Grove, California, 91945, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.